Recall Z-2915-2026 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
| Date | Aug 7, 2026 (initiated May 22, 2026) |
| Status | Open, Classified |
| Reason | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). |
| Root cause | Process control |
| Action | On 05/22/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was sent via email to customers informing them that, 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Customers are instructed to: . Identify and return any unused devices within the scope of this recall for replacement. . Complete and sign the enclosed CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com within 2 weeks of receipt of this notification. . This notice needs to be share |
| Quantity | 13 units |
| Distribution | U.S. Nationwide distribution in the states of GA and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis W. L. Gore & Associates, Inc., May 8, 2017 |